(257 days)
Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
This device is not intended for mammography and pediatric patients.
This Digital Radiography System (ManntiX K) is a portable digital device developed, designed and manufactured by Shenzhen Browiner Tech Co., Ltd. A detailed comparison table with an equivalent device are in 510(k) summary. The device consists of the following major components: portable X-ray Assembly, X-ray Protective Device, Mobile Stand, Digital Detector, image processing system. The difference between ManntiX B and ManntiX K are as below.
| Model | ManntiX B | ManntiX K |
|---|---|---|
| Portable X-ray Assembly (including collimator and tube) | PX10 | PX10 Pro |
| X-ray Protective Device (optional) | BA-01 | |
| Mobile Stand | MS-05P | MS-10P |
| Digital Detector (optional) | CareView 1500Cwe | |
| Mars1717X | ||
| Luna 1012X | ||
| Image Processing System (optional) | MOC (V03) | |
| Image Acquisition Workstation (optional) | BWS-10 |
Note:
-
- ManntiX B and ManntiX K are delivered with one of CareView1500Cwe, Mars1717X and Luna 1012X, or two of them, or three of them.
-
- A computer system, necessary for image viewing and manipulation, is not part of the device.
The major components of Digital Radiography System include: portable x-ray assembly, x-ray protective device, mobile stand, digital detector, image processing system, image acquisition workstation.
Portable X-ray assembly including collimator and tube, produces X-rays at the clinically required dose; X-ray protective device is used to protect the human body during diagnostic radiography; mobile stand is used to support or hang X-ray source components; digital detector receives X-ray signals and converts them into visible light, which is converted into electrical signals by photoelectric elements and then converted into digital signals by analog-to-digital conversion before being transmitted to the computer; image processing system has multiple functions. including new patient registration, image acquisition and processing, data transmitting, etc; image acquisition workstation is used in addition to the image processing system to adjust exposure parameters, check the status of the entire machine, and view logs.
The provided document is a 510(k) summary for a Digital Radiography System (ManntiX B, ManntiX K). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving that the device meets those criteria, especially in the context of an AI/ML-driven device's performance.
The document primarily focuses on:
- Regulatory information: FDA review, regulations, and contact details.
- Device description: Components, technical specifications (generator, detector, image processing), and intended use.
- Comparison to a predicate device: Highlighting similarities in intended use, technology, and functionality to establish substantial equivalence.
- Non-clinical performance tests: Listing compliance with various IEC and ISO standards related to electrical safety, electromagnetic compatibility, radiation protection, software lifecycle, and usability.
- Biocompatibility: Statement of evaluation according to ISO 10993-1.
There is no mention of:
- Specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) beyond general safety and electrical performance standards.
- A study proving the device meets such acceptance criteria.
- Sample sizes for test sets, data provenance, expert ground truth adjudication (for AI/ML performance evaluation), MRMC studies, standalone performance, type of ground truth used (pathology, outcomes), or training set details.
This type of 510(k) submission primarily demonstrates that the proposed device is as safe and effective as a legally marketed predicate device, often through a comparison of technical specifications and adherence to recognized standards. It does not typically involve the detailed clinical or AI/ML performance evaluation aspects you've asked about unless the device incorporates novel AI/ML components that significantly alter its diagnostic output or workflow. In this case, the device is a Digital Radiography System, which is an imaging modality, and the details provided relate to the hardware and image acquisition/processing capabilities rather than an AI/ML diagnostic aid.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.